CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,168 enrolled
Drug / intervention
Cabazitaxel (XRP6258) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01308567
NCT01308567Phase 3Completed
CompareCT.gov

Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy

Sanofi·interventional·Posted Mar 4, 2011·Updated Jun 5, 2019

In Brief

A Phase 3 clinical trial evaluating Cabazitaxel (XRP6258), Docetaxel (XRP6976), and 1 other intervention for Prostate Cancer. Completed, enrolled 1,168 participants across 167 sites in 25 countries.

Detailed Summary

Primary Objective: * To demonstrate the superiority of cabazitaxel plus prednisone at 25 mg/m\^2 (Arm A) or 20 mg/m\^2 (Arm B) versus docetaxel plus prednisone (Arm C) in term of overall survival (OS) in participants with metastatic castration resistant prostate cancer (mCRPC) and not previously treated with chemotherapy. Secondary Objectives: * To evaluate safety in the 3 treatment arms. * To compare efficacy of cabazitaxel at 20 mg/m\^2 and 25 mg/m\^2 to docetaxel for: * Progression Free Survival (PFS) (RECIST 1.1) * Tumor progression free survival (RECIST 1.1) * Tumor response in participants with measurable disease (RECIST 1.1), * PSA response * PSA-Progression free survival (PSA-PFS). * Pain response in participants with stable pain at baseline * Pain progression free survival * Time to occurrence of any skeletal related events (SRE) * To compare Health-Related Quality of Life (HRQL). * To assess the pharmacokinetics and pharmacogenomics of cabazitaxel.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesAustralia, Belarus, Brazil, Canada, China, Czechia, Denmark, Finland, France, Germany, Israel, Italy, Japan, Mexico, Peru, Poland, Portugal, Romania, Russia, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 4, 2011
Enrollment StartMay 5, 2011
Primary CompletionSep 1, 2015
Study CompletionMay 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 15.3 years ago

Interventions

Cabazitaxel (XRP6258)drug

Pharmaceutical form: Solution for injection; Route of administration: Intravenous

Docetaxel (XRP6976)drug

Pharmaceutical form: Solution for injection'; Route of administration: Intravenous

Prednisonedrug

Pharmaceutical form: Tablet; Route of administration: Oral